Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090781
Company: GLENMARK GENERICS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription AB No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription AB No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription AB No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription AB No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription AB No No
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/08/2010 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/21/2019 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
11/21/2019 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
05/10/2016 SUPPL-5 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
09/22/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
09/22/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
09/11/2015 SUPPL-2 Manufacturing (CMC)-New Strength

Label is not available on this site.

PRAMIPEXOLE DIHYDROCHLORIDE

TABLET;ORAL; 0.125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription Yes AB 020667 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 202633 AUROBINDO PHARMA LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 091450 BRECKENRIDGE PHARM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 090781 GLENMARK GENERICS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 203855 SCIEGEN PHARMS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 202702 STRIDES PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 090151 ZENNOVA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.125MG TABLET;ORAL Prescription No AB 078920 ZYDUS PHARMS USA INC

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription Yes AB 020667 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 202633 AUROBINDO PHARMA LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 091450 BRECKENRIDGE PHARM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 090781 GLENMARK GENERICS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 211088 RISING
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 203855 SCIEGEN PHARMS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 202702 STRIDES PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 090151 ZENNOVA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.25MG TABLET;ORAL Prescription No AB 078920 ZYDUS PHARMS USA INC

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription Yes AB 020667 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 202633 AUROBINDO PHARMA LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 091450 BRECKENRIDGE PHARM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 090781 GLENMARK GENERICS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 211088 RISING
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 203855 SCIEGEN PHARMS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 202702 STRIDES PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 090151 ZENNOVA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.5MG TABLET;ORAL Prescription No AB 078920 ZYDUS PHARMS USA INC

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription Yes AB 020667 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 202633 AUROBINDO PHARMA LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 091450 BRECKENRIDGE PHARM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 090781 GLENMARK GENERICS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 211088 RISING
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 203855 SCIEGEN PHARMS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 202702 STRIDES PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 090151 ZENNOVA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1MG TABLET;ORAL Prescription No AB 078920 ZYDUS PHARMS USA INC

TABLET;ORAL; 1.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription Yes AB 020667 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 202633 AUROBINDO PHARMA LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 091450 BRECKENRIDGE PHARM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 090781 GLENMARK GENERICS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 211088 RISING
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 203855 SCIEGEN PHARMS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 202702 STRIDES PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 090151 ZENNOVA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 1.5MG TABLET;ORAL Prescription No AB 078920 ZYDUS PHARMS USA INC

TABLET;ORAL; 0.75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRAPEX PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription Yes AB 020667 BOEHRINGER INGELHEIM
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 202633 AUROBINDO PHARMA LTD
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 090781 GLENMARK GENERICS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 211088 RISING
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 203855 SCIEGEN PHARMS INC
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 202702 STRIDES PHARMA
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 090865 TORRENT PHARMS
PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE 0.75MG TABLET;ORAL Prescription No AB 090151 ZENNOVA

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